Cardiff, UK. June 16, 2008: Safety assessment in drug discovery requires the in vitro genotoxicity assessment of metabolites. This is currently achieved by incubating compounds with liver extracts (‘S9’), because when genotoxicity tests were developed there was no reliable supply of fresh hepatocytes. Being able to use fresh hepatocytes for testing metabolites, instead of extracts with their limited metabolic activity, could be a major advance. This possibility has now moved a significant step closer. In the first stage of a major collaboration, Gentronix have successfully co-cultured their GreenScreen HC genotoxicity reporter cells with fresh hepatocytes preserved in Abcellute’s matrix in the presence of test material.

The results were presented by Gentronix at the recent US Society of Toxicology Meeting. According to Professor Richard Walmsley of Gentronix these results promise a major breakthrough; “We are extremely encouraged by these results. Our initial work shows that the GreenScreen HC assay can be used to assess the genotoxicity of metabolites generated by either S9 extracts or non-frozen preserved primary hepatocytes provided by Abcellute Ltd. The predictable differences in metabolism provided by S9 extracts and hepatocytes are readily apparent from the results - and represent a refinement in the use of animal material. It is now conceivable that preserved human hepatocytes could be routinely used in pre-clinical safety assessment.”

Dr Nathan Griffiths, Abcellute’s Chief Scientific Officer, said: “The results indicate the potential for our matrix in this exciting area. They match similar evaluations in our core preclinical market conducted by leading pharmaceutical companies, contract research organisations and academic institutes in Europe, the USA and Japan”.

Abcellute
Founded in 2001 and based on the work of Dr Peter Evans and Dr Nathan Griffiths, Abcellute is a product led company which exploits a patent protected cell stabilising platform technology which enables the non-frozen preservation and transport of live organ-derived cells without the loss of viability or function. The Abcellute product is currently being sold to pharmaceutical companies in Europe and Japan for pre-clinical drug testing and the company is actively expanding these sales to the USA. In the long-term, the company plans to develop the preservation technology to provide products for cell-based therapeutics.

Gentronix Ltd
Founded in 1999 by Prof Richard Walmsley at the University of Manchester, Gentronix Ltd has developed technology for the accurate identification of genotoxic compounds. GreenScreen HC is a human cell-based assay for use in screening and uses a simple, rapid and high-throughput microplate protocol. It is used by companies in the USA, EC and Japan, and is also provided by some contract service organisations.

Support
This work was supported in part by a grant from the National Centre for the Replacement, Refinement and Reduction of Animals in Research UK